Force distribution method and apparatus for neonates at risk of cranial molding

ABSTRACT

A force distribution apparatus and method are presented. Various embodiments of the disclosed apparatus include a plurality of layers configured and oriented to be deployed on a subject in a manner that disperses forces and lowers peak pressures experienced by the subject when resting on a surface, which tends to minimize risks of deformation and local ischemia. An innovative combination of novel construction methods and material selections produce an apparatus that possesses an inherent three-dimensional shape despite being built from essentially flat components, while also retaining an ability to effectively distribute forces and reduce pressures.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of and claims priority benefit ofU.S. application Ser. No. 14/504,404, filed Oct. 1, 2015, now U.S. Pat.No. 9,173,763, which claims priority to U.S. Provisional ApplicationSer. No. 62/012,795, filed Jun. 16, 2014, entitled “PressureDistribution for Neonates at Risk of Cranial Molding”, to U.S.Provisional Application 61/885,486, filed Oct. 1, 2013, entitled “BonnetFor Preventing & Treating Neonatal Cranial Molding & Skin Breakdown”,and to U.S. Provisional Application Ser. No. 61/947,203 filed Mar. 3,2014, entitled “Pressure Distribution for Neonates at Risk of CranialMolding”, the contents of each of which are incorporated herein in theirentireties by this reference. This application also references U.S.Non-Provisional application Ser. No. 13/642,034, filed Apr. 21, 2011,entitled “Neonatal Cranial Support Bonnet”, which claims priority toprovisional application U.S. Provisional Application Ser. No.61/327,647, filed Apr. 23, 2010, both of which are also incorporatedherein in their entirety by this reference.

BACKGROUND OF INVENTION

1. Field of the Invention

The present invention particularly relates to medical devices andmethods that prevent, minimize and/or treat cranial molding in neonatalsubjects, most especially for human subjects born prematurely. Moreparticularly, the present invention relates to such medical devices andmethods that distribute cranial interface pressures and correspondingforces routinely encountered during care of such neonatal subjects,primarily for reducing risks of cranial deformation and potentiallyassociated developmental impairment or delay.

2. Description of Related Art

As a neonatal human subject lies in a supine position, forces areimparted at areas of contact between the subject and the surface onwhich the subject lies. When the subject is lying in a supine (backdownward) position, a contact area exists generally on the occipitalregion of the subject's head.

In the mid-1990s, the “Back to Sleep” (BTS) campaign was initiated toaddress the problem of sudden infant death syndrome (SIDS). It washypothesized that a risk factor associated with SIDS in infants wassleeping in a prone position and that switching infants to a supineposition that the incidence of SIDS would decrease. In one study of 568SIDS cases occurring before and after the initiation of the BTS campaignin about 1994, a sudden decrease in the rate of SIDS cases from 1.34 per1,000 births in 1991 to 0.64 per 1,000 births in 2008 occurred. Thestudy also showed that, over that same period, the percentage of SIDSinfants placed to sleep prone decreased from 85.4% to 30.1% and thatthose found prone decreased from 84.0% to 48.5%, whereas those placedsupine increased from 1.9% to 47.1%. Such findings indicate overall thatmore infants were placed supine at the time that the SIDS rate wasdeclining precipitously (Trachtenburg F L et al, “Risk Factor Changesfor Sudden Infant Death Syndrome After Initiation of Back-to-SleepCampaign”, Pediatrics 2012; 129; 630).

Largely attributed to the BTS campaign, there has been a simultaneousincrease in the occurrence of cranial molding, including deformationalplagiocephaly. Deformational plagiocephaly (DP) refers to asymmetry orflattening of the infant skull secondary to external force. While DP haslong been an occasional condition in neonatal subjects in general, theincidence of DP has steadily increased over the past twenty years, froman estimated 5% in the mid-1990s to 20-30% currently. Such cranialdeformation, unfortunately, may not merely be a cosmetic condition.Evidence suggests that children with deformational plagiocephaly have anincreased risk for developmental impairment or developmental delay,perhaps because brain parenchyma shifts to conform to positional skulldeformities.

In spite of the long history and steady increase in the incidence ofcranial molding, optimal solutions have not been presented. It is knownthat some orthotics are used in an attempt to ameliorate suchconditions, yet the cranial molding rate remains high, and many otherchallenges and obstacles encountered with the prior art remainunresolved.

Many other advantages, disadvantages, problems and challenges of theprior art are known and will be evident to those of ordinary skill inthe art, particularly after reading this specification and contemplatingits implications.

BRIEF SUMMARY OF THE INVENTION

It is a fundamental object of the present invention to minimize andovercome the obstacles and challenges of the prior art, especially inways that contribute to improved health and wellbeing of those who aresuffering or are at risk of suffering from deformational plagiocephaly,as well as to facilitate and enable effective yet easy and affordableinterventions and techniques for achieving such improved health andwellbeing. While numerous secondary objects may also be addressed, themost pressing objectives relate especially to the care of neonatal humansubjects who are born prematurely and who suffer or are at risk ofsuffering complications due to cranial molding and related developmentalconditions.

In the following descriptions and accompanying drawings, numerousdetails are set forth and illustrated to provide a more thoroughunderstanding of preferred embodiments of the present invention. It willbe apparent, however, to one skilled in the art, that embodiments of thepresent invention may be practiced without these specific details. Asused herein, unless otherwise indicated, “or” does not require mutualexclusivity.

In many embodiments of the invention, force-distributing apparatus areprovided for use on a subject such as a human. Such force-distributingapparatus are generally adapted to disperse the forces imparted to thesubject's tissue due to the weight of the subject on an external supportsurface, thereby reducing the pressure resulting from the applied force.Preferred embodiments of the present invention are often in the form ofa force-distributing cranial support, which is sometimes referred to asa pressure reducing cranial support, a force-distributing apparatus, a“bonnet”, or a “protector.” In some embodiments, the force-distributingcranial support is designed, structured, sized, and secured to asubject's head in order to distribute cranial and skin interfacepressures while reducing point loads encountered between the subject'shead and a mattress, pad or other underlying support surface on whichthe subject's head is positioned to rest. In other embodiments, thepressure reducing cranial support is designed, structured, and sized tobe positioned on a pediatric head and in other embodiments on an adulthead. The pressure reduction apparatus may take other forms permittingthe pressure reduction apparatus to be affixed over a bony protuberanceof the human, the bony protuberance including but not limited to apelvic region, an elbow, or the heel of the foot.

When so placed on the subject, the force-distributing apparatus, becauseof its particular features and characteristics, distributes externalforces away from the area of contact between the tissue and an externalsurface, as smaller forces over a larger area. Such smaller forces overthe larger area, in turn, result in less applied pressure. Accordingly,without being limited to any particular theory, by distributing thenormal forces applied to the cranial bones when the infant is layingsupine, the infant's brain parenchyma within the cranial cavity may bemore likely to grow essentially in a radial manner and less likely tohave growth restricted to cranial portions not experiencing high normalforces.

When affixed to the head of the infant, the force-distributing cranialsupport is configured to reduce compressive forces on soft, flexiblecranial plates that define a cranial cavity. The force-distributingcranial support cradles the head, further promoting the properdevelopment of the infant's head, reducing the incidence or preventingthe development of plagiocephaly, brachycephaly, and dolichocephaly(referred to collectively as, “positional cranial molding” or, simply,“cranial molding”), as well as other forms of skeletal deformation. Suchreduction of the development of cranial molding is also thought to aidin the prevention and treatment of other related disorders and diseasesin neonatal subjects—most notably by permitting the normal growth ofbrain tissue within the cranial cavity, perhaps positively affectingcognitive development.

Though not the primary object of the present invention, due to thesurprising ability to distribute pressures with minimal encumbrancearound the subject, embodiments of the invention are also able to reduceskin interface pressures and, hence, can also be used secondarily toprevent diseases and disorders caused by prolonged or excessive skininterface pressures. The distribution of pressure may also reduce skininterface pressures on areas of the soft tissue where compressive forcesare otherwise concentrated and, hence, tend to cause partial or completecapillary collapse. Such capillary collapse may lead to pressure ulcers,pressure sores, skin breakdown, decubitus ulcers, or otherpathophysiologic conditions. The force-distributing apparatus may thusbe prophylactically affixed to the human in a manner to distributepressure in an at-risk area to prevent such pathophysiology.

Beyond prevention, in the event that initial cranial molding or skinbreakdown is observed, preferred methods of the invention promptcaregivers to interventionally secure the force-distributing cranialsupport in a corresponding position on the subject's head, both to helpin treatment of the deformation or skin breakdown, as well as to preventfurther harm. The treatment aspects are enabled by the ability of theforce-distributing cranial support to distribute external cranial forcesand to distribute and reduce skin interface pressures on the areas ofthe subject's head where compressive forces are otherwise concentratedand, hence, tend to cause partial or complete capillary collapse. Bydistributing and reducing as much, the force-distributing cranialsupport thereby helps treat and allow natural healing of tissue that hasalready partially deteriorated due to pressure points.

In some embodiments of the invention, a force-distributing cranialsupport has a concavely shaped occipital cup portion and a contiguoushead strap portion shaped and sized to circumferentially envelope thehead of an infant while leaving the crown and face of the head exposed.The occipital cup portion and the head strap portion each comprise apatient-oriented face configured to be proximate the skin of the headwhen in use and an environmental-oriented face configured to face awayfrom the skin of the head when in use. The occipital cup portion furthercomprises a force-distributing assembly of one or moreforce-distributing elements where the force-distributing elements may bea semi-solid material or, more preferably a gel, or still morepreferably a hydrogel.

The materials and dimensions of the force-distributing assembly of theforce-distributing cranial support are such that when the head of theinfant who is lying in a supine repose on a surface is so enveloped, theforce-distributing assembly distributes the force applied at a contactpoint on the surface over a larger area and thus disperses the pressureassociated with the weight of the infant's head. Further, the head strapportion is dimensioned and oriented to secure the occipital cup portionagainst the posterior aspect of the infant's head. The occipital cupportion and the head strap portion comprise a readily cleanable,hypoallergenic, biocompatible, and non-irritating material that isselectively coated with a grip-providing material. Preferably thegrip-providing material is oriented on a side of the force-distributingcranial support that contacts the infant's head. In other embodiments ofthe invention, the force-distributing cranial support also includes apadded layer within, oriented essentially adjacent to theforce-distributing assembly, both the force-distributing assembly andthe padded layer assuming the concavity of the occipital cup portion.

These and many other aspects of the invention will be understood bythose of skill in the art in light of any claims that are or may laterbe associated with this patent application, especially when contemplatedin light of various embodiments of the invention that are illustrated inthe accompanying drawings and are further described on the followingpages of this application, as well as the many other embodiments thatcould now or in the future also fall within the scope of those claims.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 shows a perspective view of a force-distributing cranial support100, which is representative of preferred embodiments constructedaccording to the teachings of the present invention, and which is formedto fit on a head 210 (shown in phantom lines) of a prematurely-bornneonatal subject 200;

FIG. 2 shows a further perspective view of a representative preferredembodiment of the force-distributing cranial support 100 of FIG. 1,although FIG. 2 shows the support 100 laid flat in an opened state, notfitted to the head of the subject;

FIG. 3 shows an exploded diagram of many of the various layers and otherelements that are united during manufacture to form theforce-distributing cranial support 100 of FIG. 1;

FIG. 4 shows a perspective view of a variation of force-distributingcranial support 100 in its operative orientation on neonatal head 210much as in FIG. 1, while FIG. 2 further illustrates the incorporation ofpressure sensors 164 (shown in hidden line) and an associated display166 to enable feature enhancements not illustrated in FIG. 1;

FIG. 5 shows a variation 100′ of force-distributing cranial support 100in a perspective view, as operatively oriented on the head of a neonatalsubject, with particular detail to illustrate an anchor system 168 foran accessory securement system 172;

FIG. 6 shows a representative preferred embodiment of an anchorapparatus 170 in a perspective view, as part of the anchor system 168and related components illustrated in FIG. 5;

FIG. 7 shows a representative preferred embodiment of a connectingmember 184 in a front view, which forms part of the preferred accessorysecurement system 172 illustrated in the FIG. 5 variation 100′ offorce-distributing cranial support 100;

FIG. 8 shows a perspective view of a representative preferred embodimentof an accessory adapter 188, which is part of an alternative embodimentof the accessory securement system 172 illustrated in the FIG. 5variation 100′ of force-distributing cranial support 100;

FIG. 9 shows a plot of the percent differences in peak pressuresimparted to a subject positioned on a hard surface, the differencesbeing between the peak pressures with and without the subject using aforce-distributing cranial support comparable to support 100 of FIG. 1;and

FIG. 10 shows a plot of the percent differences in contact areas betweena subject and a hard surface, the differences being between the contactareas with and without the subject using a force-distributing cranialsupport comparable to support 100 of FIG. 1.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

A good understanding of the broader aspects of the present invention canbe gleaned from consideration of several of the presently preferredembodiments that are depicted in and described with reference to FIGS.1-10 of the drawings, where like numerals are used for like elements inthe various embodiments. Occasional paragraph or section headings havebeen used for ease of reference, but such headings generally should notbe read as affecting the meaning of the descriptions included in thoseparagraphs/sections.

Referring to FIG. 1, in various preferred embodiments, aforce-distributing cranial support 100 is shaped and adapted to conformto a subject's head 210 in an orientation as generally illustrated inFIG. 1, which is referred to as the “operative position” offorce-distributing cranial support 100. As will be evident to those ofskill in the art, particularly after contemplating the furtherdescriptions of this specification, force-distributing cranial support100 is especially adapted to protect the head 210 of a prematurely-bornneonatal subject 200 against cranial molding and other complications.

The force-distributing cranial support 100 generally has anenvironmental oriented face 104 and a patient oriented face 106, whichprovide the outer surfaces surrounding a multi-layered cushion assembly136, which preferably includes a gel assembly 138 as described furtherherein. In some embodiments, the environmental oriented face 104 furthercomprises a medial environmental-face component 108 and two lateralenvironmental-face components 110 a and 110 b (the latter being numberedin FIG. 3). The patient oriented face 106 is oriented opposite theenvironmental oriented face 104. The force-distributing cranial support100 further comprises a cephalic edge 112 and a caudal edge 114, whichin use orients the cephalic edge 112 towards a crown 211 of thesubject's head 210 and the caudal edge 114 towards a neck 116 of thesubject.

In part to help distribute forces encountered by the occipital region212 of the head 210 of the subject 200 when the subject is lyingsupinely in a neonatal bassinet or neonatal incubator, theforce-distributing cranial support 100 comprises an occipital cupportion 118, which in use is snugly positioned proximate the occipitalbone in the occipital region 212 of the subject's head 210.

The force-distributing cranial support 100 also has a head strap portion120, which preferably is formed by one or more integral portions of theforce-distributing cranial support 100. The structure, shapes andconfiguration of the head strap portion 120 are such that, while theoccipital cup 118 is snugly positioned in its operative position on theoccipital region 212 of head 210, head strap portion 120 provides acircumferential closure around the forehead 214 of subject 210, therebysnugly enveloping the forehead 214, while also serving to further secureboth the occipital cup 118 and the overall support 100 in theirrespective operative positions. Head strap portion 120 preferablyincludes conventional releasable closure adaptations such that portion120 provides a releasable circumferential closure around the forehead214 of subject 210, to secure both the occipital cup 118 and the overallsupport 100 in their respective operative positions.

In use, the force-distributing cranial support 100 adopts athree-dimensional structure that is essentially symmetrical about avertical plane extending between the furthest points of the occipitalcup portion 118 and the head strap portion 120, the vertical planedefining a first side and a second side of the force-distributingcranial support 100.

The occipital cup portion 118 may further comprise caudal tabs 122bilaterally extending along the caudal edge 114 of a first side and asecond side of the force-distributing cranial support 100, thus orientedproximate a jaw of the subject's head 210. The head strap portion 120may further comprise a first wing 124 a and a second wing 124 b, thefirst wing 124 a and the second wing 124 b extending from the occipitalcup portion 118 along the cephalic edge 112. The first wing 124 a andthe second wing 124 b are releasably attachable, preferably carrying ahook and loop fastener material to provide a secure releasableattachment, together the releasably attached first and second wings 124a and 124 b form the head strap portion 120. However, any suitablefastening mechanism such as snaps, for example, could be used instead.In other embodiments, the head strap portion 120 may include a bandaffixed to the occipital cup portion 118 proximate the cephalic edge112. The band and the occipital cup portion 118 may each carry areleasable attachment mechanism, for example a hook and loop fastenermaterial between the occipital cup portion 118 and the head strapportion 120. The head strap portion 120 may further comprise an elasticmaterial to provide a compression force sufficient to maintain theforce-distributing cranial support 100 on the subject's head 210.

Referring now to FIGS. 1 and 2, the occipital cup portion 118 mayfurther comprise ear-accommodating arches 126 defined on one side by thecaudal tabs 122 and on the other side by a lower aspect of the wings 124a and 124 b. In use, the force-distributing cranial support 100 ispositioned in its operative position on the head 210 of the subject, inan orientation such that the ear-accommodating arches 126 are proximatethe posterior aspects of the ears 219 a and 219 b of the subject. Insuch operative position, the force-distributing cranial support 100 ispositioned for distributing forces that would otherwise be encounteredby the occipital region 212 of the head 210 of the subject 200 when thesubject is conventionally lying in a supine position on a neonatalbassinet and/or neonatal incubator.

Referring now to FIG. 2, in one embodiment, the occipital cup portion118 may comprise a caudal rim member 128 oriented essentially proximatethe caudal edge 114 and positioned under the patient oriented face 106.So oriented, when in use, the caudal rim member 128 protrudes towardsthe subject's head 210 and below an occipital protuberance of thesubject's head 210. The caudal rim member 128 is positioned and orientedrelative to the occipital protuberance to resist migration of theforce-distributing cranial support 100 off the subject's head 210 duringordinary movement. The caudal rim member 128 is preferably an elongatedpolyethylene foam element oriented between the patient oriented face 106and the environmental oriented face 104, however, the caudal rim member128 may also be any other foam or gel element or any other malleablebolster material. In dimension, the caudal rim member 128 is preferablyessentially the width of the occipital cup portion 118 along the caudaledge 114 thereof, although the caudal rim member 128 may also be asnarrow as about 2 cm, centered along the caudal edge 114 to the sameeffect. The extent to which the caudal rim member 128 protrudes from thepatient oriented face 106 is preferably between about 0.2 cm and about 1cm although in some circumstances this distance may be as large as about1.5 cm.

In other embodiments (not shown), the occipital cup portion 118 may alsocomprise two ridge members secured to the environmental oriented face104. The two ridge members are preferably elastic foam or foam-filledstructures that protrude outwardly to serve as mini-bolsters to aid inpositioning of the subject's head 210. The two ridge members aredimensioned and positioned to provide stability to the subject's head,resisting a rolling motion. In an embodiment, the two ridge members arelocated essentially on opposite sides of line L, oriented approximatelyparallel to line L and between about 1 cm and about 3 cm from line L. Inother embodiments, the two ridge members are removably affixable to theenvironmental oriented face 104 with a hook and loop securementmechanism, configured to allow repositioning of the two ridge members todifferent positions on the environmental oriented face 104 to stabilizethe subject's head 210 in a variety of positions as dictated orsuggested by clinical care.

Referring now to FIG. 1 and FIG. 2, an embodiment of theforce-distributing cranial support 100 is shown. A flexible piping 130extends essentially around the perimeter of the force-distributingcranial support 100 secured to both the environmental oriented face 104and the patient oriented face 106, or to a seam therebetween. The piping130 may further comprise a cord or a foam rod- or tube-like structureand an elongated band of flexible fabric material. Although variouspiping techniques could be suitable, the band of flexible fabricmaterial is preferably turned to define a general piping shape, and itslongitudinal edges are preferably folded-under along its length, toprovide opposite longitudinal edges for providing a felled seam, onealong each of its longitudinal edges. As is conventional for piping, onesuch felled seam of the elongate fabric material may be sewn orotherwise joined around the perimeter of the patient oriented face 106,and the other such felled seam may be sewn or otherwise joined aroundthe perimeter of the environmental face 104, and the cord or foamstructure is then held within the turned band of material.

In other embodiments, the piping 130 extends essentially around theperimeter of the force-distributing cranial support 100 with theexception of the most distal portion of the first and second wings 124 aand 124 b, for instance, leaving the distal most one to five centimeterswithout any piping. This may allow the distal tip of each of the firstand second wings 124 a and 124 b to taper to a thinner dimension thanthe rest of wings 124 a and 124 b, which in turn helps accommodateoverlap of such distal tips as well as the incorporation ofhook-and-loop or other releasable closure connections in such distaltips in order to render the tips releasably connectable to one another.

Referring now to FIG. 2, an embodiment of the force-distributing cranialsupport 100 is shown in an opened state and portraying the patientoriented face 106. A cephalic edge arch 132 is essentially centered onthe force-distributing cranial support 100 along the cephalic edge 112.Similarly, a caudal edge arch 134 is oriented essentially in the centerof the force-distributing cranial support 100 along the caudal edge 114.

Referring now to FIG. 3, an exploded view of a preferred embodiment ofthe invention is shown. The force-distributing cranial support 100 isfabricated from a plurality of layers that provide for novel shaping andforce-distribution and pressure reduction characteristics. A cushionassembly 136 is oriented between the environmental oriented face 104 andthe patient oriented face 106 within the occipital cup portion 118, thecushion assembly 136 preferably includes a gel assembly 138 cushionedwith one or more pad layers. In other embodiments, the gel layer 144comprises one or more cushion elements. In some embodiments, the cushionassembly 136 is a force-distributing assembly. Preferably, the gelassembly 138 is sandwiched between an inner pad layer 140 and an outerpad layer 142. In one embodiment, the gel assembly 138 comprises a gellayer 144 encapsulated between an inner envelope layer 146 and an outerenvelope layer 148. In some preferred embodiments, the gel layer 144further comprises a medial gel element 150, two lateral gel elements 152a and 152 b, and an inferior gel element 153 or caudal gel element 153.In some embodiments, the medial gel element 150, the two lateral gelelements 152 a and 152 b, and the inferior gel element 153 are each asemi-solid material.

The inner envelope layer 146 and the outer envelope layer 148 may besealed about a perimeter so as to encase the medial gel element 150, thetwo lateral gel elements 152 a and 152 b, and the inferior gel element153. The inner envelope layer 146 and the outer envelope layer 148 mayalso be sealed or partially sealed between the medial gel element 150,the two lateral gel elements 152 a and 152 b, and the inferior gelelement 153, such sealing serving to fix each gel element 150, 152 a,152 b, and 153 in its proper position during use, while also serving toisolate or separate each of the gel elements 150, 152 a, 152 b, and 153from one another. The sealing may be accomplished through a heat-sealingprocess, a welding process, an application of an adhesive, or any othersuitable process or mechanism. These seals generate seams between thevarious components. The seams provide a flexible bend region tofacilitate the assembly of the force-distributing cranial support 100.

In one embodiment, the inner pad layer 140 is positioned essentiallyparallel and proximate both the gel assembly 138 and the patientoriented face 106. The outer pad layer 142 may be positioned essentiallyparallel and proximate both the gel assembly 138 and the environmentaloriented face 104. The inner pad layer 140 may be adhered to the patientoriented face 106 with an adhesive, and the outer pad layer 142 may beadhered to the environmental oriented face 104 with an adhesive, theadhesive preferably being an acrylic adhesive. Preferably, the outer padlayer 142 may further comprise a medial outer pad element 154, twolateral pad elements 156 a and 156 b. The outer pad layer 142 may alsobe laterally flanked by two outer wing pad elements, 158 a and 158 b.Similarly, the inner pad layer 140 may be laterally flanked by two innerwing pad elements 160 a and 160 b. The four wing pad elements 158 a, 158b, 160 a, and 160 b are positioned thus lateral to the gel assembly 138and positioned in the first wing 124 a and the second wing 124 b of theforce-distributing cranial support 100 between the environmentaloriented face 104 and the patient oriented face 106. The two inner padwing elements 160 a and 160 b and the two outer pad wing elements 158 aand 158 b may be adhered to the appropriate proximate first wing 124 aand second wing 124 b with an acrylic adhesive or other suitableaffixing agent. In other embodiments, two inner pad wing elements 160 aand 160 b and the two outer pad wing elements 158 a and 158 b may beadhered to the gel assembly 138 with an acrylic adhesive or othersuitable affixing agent.

The environmental oriented face 104 and the patient oriented face 106may be the same type of material or may be different. Both faces 104 and106 may comprise a flexible textile that is preferably capable ofstretching to conform to an externally applied force which can, thus,minimize or even prevent an accompanying increase in interface pressure.The textile may also recover from such aforementioned stretch, returningto its original condition and shape. In some preferred embodiments, thetextile is configured to have a low friction surface that reduces shearwhen laterally shifted in relation to an interfacing surface. In somepreferred embodiments, the textile is hypoallergenic, biocompatible, andnon-irritating. By way of a non-limiting example, the textile may beRecovery 5™ Healthcare Fabric or preferably Recovery 5™ HF HealthcareFabric (Staftex Textiles Limited, Toronto, Canada).

The textile of faces 104 and 106 may also permit water vapor transfer tofacilitate the movement of perspiration from the human subject to andpreferably through one or more of the plurality of layers of theforce-distributing cranial support 100 and may be configured formoisture vapor transfer between about 200 gr/m2/24 hrs to about 900gr/m2/24 hrs. By way of a non-limiting example, the textile may beEstane® 58245 (Lubrizol, Cleveland, Ohio, USA). The textile may alsocomprise a combination of these stretch and moisture vapor transfercharacteristics in one or more segments.

The textile of faces 104 and 106 may further comprise an antimicrobialagent or may have antimicrobial properties. The antimicrobial agent maybe Ultra-Fresh DW-30® (Thomson Research Associates, Toronto, Canada)although many other biocompatible antimicrobial agents may be suitablealso.

In some embodiments, the force-distributing cranial support 100 furthercomprises a grip-providing substance 162 or gripping material affixed tothe patient oriented face 106 and oriented proximate the subject's head210 when in use. The grip-providing substance 162 may cover the entirepatient oriented face 106, or the grip-providing substance 162 may beconfigured in a pattern, covering only a portion of the patient orientedface 106. The pattern of the grip-providing substance 162 may be one ormore stripes, one or more ellipses, one or more regular polygons, one ormore dots, one or more lines essentially parallel to or perpendicular tothe cephalic edge 112, other shapes, or a combination of any of these.The grip-providing substance 162 may be generally oriented on theoccipital cup portion 118, generally on the head strap portion 120, oron both. In some preferred embodiments, the grip-providing substance 162is oriented both along a portion of the patient oriented face 106 of thehead strap portion 120, in a pattern on the occipital cup portion 118,and over the caudal rim member 128. In some embodiments, the pattern ofthe grip-providing substance 162 on the occipital cup portion 118assumes the shape of an ellipsis or a polygon oriented essentiallyaround the center of the occipital cup portion 118 while leaving thecenter of the occipital cup portion 118 uncovered by the grip-providingsubstance 162.

In an illustrative embodiment, the grip-providing substance 162 soapplied to the occipital cup portion 118 may help minimize movement ofthe force-distributing cranial support 100 when affixed to the subject'shead 210. The grip-providing substance 162 in some preferred embodimentscomprises a cured silicone such as Bluestar TCS 7536 Silicone (BluestarSilicones, East Brunswick, N.J., USA). In other embodiments, thegrip-providing substance 162 may comprise Mediderm 3200 or Mediderm 4000(Mylan Technologies, St. Albans, Vt.), although other grip-providingmaterials such as polysiloxane may also be used. In some embodiments,the grip-providing substance 162 has a thickness between about 10microns and about 10 millimeters, preferably between about 50 micronsand about 250 microns.

The inner pad layer 140 and the outer pad layer 142 may each comprise apolyethylene foam known to be medical grade and hypoallergenic. In otherembodiments, the inner pad layer 140 and the outer pad layer 142 mayeach comprise a polyurethane foam known to be medical grade andhypoallergenic. By way of a non-limiting example, the polyethylene foammay be MDFT3500 (CCT Tapes, Philadelphia, Pa., USA) although other foammaterial may be used in other embodiments. In other embodiments, thepolyethylene foam may be TM-6563 (MacTac, Stow, Ohio, USA). Thepolyethylene foam may be coated on one or both sides with an adhesivesuch as an acrylic adhesive. In some embodiments, the inner pad layer140 and the outer pad layer 142 are dimensioned less than about 10millimeters, more preferably less than about 5 millimeters and morepreferably about 1 millimeter in thickness. The thickness dimensioningof the inner pad layer 140 and the outer pad layer 142 providessufficient flexibility to allow the force-distributing cranial support100 to follow the contours of the subject's head 210.

In one embodiment the gel elements 150, 152 a, 152 b, and 153 of the gellayer 144 are comprised of a hydrogel. The hydrogel may contain betweenabout 10% and about 99.9% water, preferably between about 15% and about70% water, and more preferably between about 35% and about 50% water.More preferably still, the water content of the hydrogel is about 40%.The gel layer 144 may be a proprietary hydrogel KM501 from Katecho, Inc.(Katecho, Des Moines, Iowa, USA). The hydrogel provides a semi-solidviscoelastic gel material that is resistant to flow or oozing and yet,surprisingly, provides a soft resilience to compression from anexternally applied force and simultaneously provides a distribution ofthat externally applied pressure. The gel layer 144 is relatively thin,being dimensioned to have a thickness between about 2 mm and 20 mm, orpreferably between about 4 mm and about 15 mm, or more preferably stillbetween about 6 mm and about 10 mm.

The inner envelope layer 146 and the outer envelope layer 148 may eachcomprise a thermoplastic elastomer, preferably configured as pliable andhaving an ability to be stretched without becoming deformed. Preferably,the thermoplastic elastomer possesses a moisture vapor transfer rate(MVTR) below about 15 grams per square meter per day such that thehydrogel contained therein will be less inclined to lose waterconcentration due to evaporation. The thermoplastic elastomer may be athermoplastic elastomer alloy such as Versaflex™ CL2250 (PolyOne,McHenry, Ill., USA) and may be dimensioned between about 0.5 mm and 5 mmin thickness, preferably about 0.8 mm in thickness.

In other embodiments, a desiccant is contained within theforce-distributing cranial support 100, preferably within the pad layer140 or inner envelope layer 146, such desiccant is preferably adapted toabsorb moisture from the subject that passes through the patientoriented face 106. As alternatives, the desiccant may be oriented withthe inner pad layer 140, the outer pad layer 142, or as a powder orpellets situated between any of the plurality of layers of theforce-distributing cranial support 100. So positioned, the desiccant mayprovide a moisture gradient from the subject to the force-distributingcranial support 100 to promote the transmission of moisture away fromthe subject. Other powered or non-powered means may also be substitutedfor, or used in conjunction with such desiccant to enhance the moisturegradient.

In other embodiments, the gel assembly 138 further comprises one or moreregions wherein the inner envelope layer 146 and the outer envelopelayer 148 are adhered or bonded together selectively, for instance bywelding, in one or more regions to limit the effective thickness of thegel assembly 138 in that region thus preventing the gel layer 142 movingthrough or existing in the one or more regions. These one or moreregions may be linear, circular, curvilinear, or any polygon in shape.In use, these one or more regions may limit the movement of the gellayer 142 within the gel assembly 138 in a manner so as to maintain gelthroughout the gel assembly 138 even as an external force is appliedlocally thereon.

The force dispersing properties and the concave curvature of theoccipital cup portion 118 are facilitated by the interacting shapes ofeach gel element 148, 152 a, 152 b, and 153, each outer pad layerelement 154, 156 a, and 156 b, and each environment-face component 108,110 a, and 110 b, which shapes are characterized in part by theirvarious edges. The edges of the medial outer pad element 154 facing thetwo outer lateral pad elements 156 a and 156 b are essentially shaped asan obtuse angle. Similarly, the edges of each of the two lateralenvironmental-face components 110 a and 110 b facing the medialenvironmental-face component 108 are shaped as obtuse angles also.

Referring again to FIG. 1, the shape and other characteristics of theoccipital cup 118 and wings 128 a, 128 b of force-distributing cranialsupport 100 allow the support 100 to be operatively positioned on thesubject's head 210 in a way that distributes forces that would otherwiserisk cranial molding, while simultaneously allowing open access tovarious key surfaces of the subject's head 210. Particularly, theforce-distributing cranial support 100 has an inherent three-dimensionalcharacteristic suited to circumferentially envelope or wrap around thehead 210 of the subject 200 while preferably leaving the crown 211 ofthe subject's head 210 exposed for therapeutic or diagnostic access. Aswill also be appreciated from the operative position illustrated in FIG.1, the preferred operative position of force-distributing cranialsupport 100 also leaves the subject's face 215, frontal neck 225, andears 219 a and 219 b unobstructed. Hence, the subject 200 retains itsnatural abilities to use its hearing and vision senses, as well as itsnose 217 and mouth 218, substantially unimpeded despite havingforce-distributing cranial support 100 secured in its operative positionon head 200. To effectively distribute force externally applied to thesubject's head 210, the force-distributing cranial support 100 willideally be essentially in contact therewith. However, the environmentaloriented face 104, the patient oriented face 106, the gel assembly 138,inner pad layer 140, and the outer pad layer 142 are all essentiallyflat, having no inherent concavity in preferred embodiments. Despitesuch lack of inherent concavity, the combined shapes, construction, andmaterials uniquely combine to promote a concave structure.

Referring again to FIG. 3, it was surprisingly found that by shaping theopposing edges of medial environmental-face component element 108 andthe lateral environmental-face components 110 a and 110 b as obtuseangles, that when stitched together transform the individualtwo-dimensional elements into a three-dimensional concave form. Further,by matching the shapes and angles of the medial environmental-facecomponent element 108 and the lateral environmental-face components 110a and 110 b with the medial outer pad element 154 and the lateral outerpad elements 156 a and 156 b, the outer pad layer 142 can then beaffixed to the concave shape of the environmental oriented face 104maintaining this shape. Most surprisingly, it was also found that thegel assembly 138 with the gel elements 150, 152 a, and 152 b could beforcibly affixed to the concave shape of the outer pad layer 142, withthe flexible seams between the gel elements 150, 152 a, and 152 bproviding sufficient conformability because of the particular shapes ofthe seams and of the gel elements 150, 152 a, 152 b, and 153. In anotherembodiment, it was found that that the gel assembly 138 with the gelelements 150, 152 a, and 152 b could be forcibly affixed directly to theconcave shape of the environmental face 104, aligning the flexible seamsbetween the medial gel element 150 and the first and second lateral gelelements 152 a and 152 b with the shapes and angles of the medialenvironmental-face component element 108 and the lateralenvironmental-face components 110 a and 110 b, thus resulting in the gelassembly 138 adopting the concavity of the so assembled environmentalface 104.

The radius of the resulting concavity is such that the occipital cupportion 118 conforms to the convex shape of the subject's head 210,tucking under the occipital protuberance. It was also found thatgenerating concavity from the two-dimensional materials of theforce-distributing cranial support 100 was further promoted bydimensioning the height along line L of the environmental oriented face104 and the patient oriented face 106 slightly differently. Specificallyand surprisingly, dimensioning the height of the patient oriented face106 between only about 2 mm to 5 mm less than the height of theenvironmental oriented face 104 contributed to a cupping effect when thetwo faces 104 and 106 are joined in construction.

In the gel layer 144, the medial gel element 150 may be between about 2cm and about 8 cm at its widest dimension and between about 1 cm andabout 4 cm at its narrowest dimension. The distance separating themedial gel element 150 and each of the lateral gel elements 152 a and152 b is between about 0.2 cm and about 1 cm, approximately equidistantalong a curved path. The overall width of each of the lateral gelelements 152 a and 152 b is between about 2 cm and about 10 cm. Theencapsulated inferior gel element 153 follows a curve defined by thebase of the medial gel element 150 and the two lateral gel elements 152a and 152 b, separated by between about 0.2 cm and about 1 cm andextending in width between about 2 cm and about 10 cm. Orthogonal to thewidth of the medial gel element 150, the height of the medial gelelement 150 is between about 2.5 cm and about 10 cm. When combined withthe separation between the medial gel element and the encapsulated gelelement of the inferior gel element 153, the height of the collection ofgel elements 150, 152 a, 152 b, and 153 of the gel layer 144 is betweenabout 4 cm and about 11 cm.

Another component of the gel assembly 138, the inner pad layer 140 isdimensioned with a similar aspect ratio to the gel assembly 138, scaledbetween about 110% and about 50% of the gel assembly 138, preferablybetween about 85% and about 75%. The medial outer pad element 154 isshaped similarly to the medial gel element 150 and is dimensionedbetween about 90% and about 120% of the medial gel element 150.

In some embodiments, taken together, the force-distributing cranialsupport 100 is dimensioned to fit a head. In some preferred embodiments,the force-distributing cranial support 100 is dimensioned to fit thehead of an infant. To facilitate proper sizing to a range of infantsfrom premature to toddler, the force-distributing cranial support 100may be constructed in multiple sizes, for instance a small, a medium,and a large unit. By way of an illustrative example, the small size maybe dimensioned to fit the head of an infant with a circumference at thewidest plane from about 23 cm to about 30 cm, the medium from about 28cm to about 33 cm, and the large from about 33 cm to about 38 cm. Toprovide for this, given sufficient overlap of the first and second wings124 a and 124 b, in one preferred embodiment the tip-to-tip measurementof the patient oriented face 106 as shown in FIG. 2 may be about 34 cmfor the small size, about 41 cm for the medium size, and about 48 cm forthe large size. The height of the force-distributing cranial support 100along line L of FIG. 2 from the caudal edge 114 to the cephalic edge112, in some preferred embodiments, is about 60 mm for the small size,about 76 mm for the medium size, and about 90 mm for the large size. Thewidth of the occipital cup portion 118, as defined by the edge-to-edgemeasurement at the bilateral ear accommodating arches 132, in anembodiment is about 7 cm for the small size, about 10 cm for the mediumsize, and about 15 cm for the large size. It is understood that toaccommodate heads of other sizes, that appropriately proportioneddimensions could be readily used for the force-distributing cranialsupport 100 without deviating from the invention.

As noted in the description of the composition of the gel layer 144previously, the gel layer 144 is thin. When combined with the othercomponents of the cushion assembly 136, the cushion assembly 136 is alsothin. The inner pad layer 140 and the outer pad elements 154, 156 a, and156 b may have an uncompressed thickness of between about 0.5 mm andabout 5 mm, preferably between about 1 mm and about 2 mm. Thus thecombined thickness of the cushion assembly 136 is between about 3 mm andabout 30 mm, preferably between about 6 mm and about 14 mm and theoverall thickness of the force-distributing cranial support 100 at theoccipital cup portion 118 is between about 5 mm and about 32 mm,preferably between about 8 mm and about 16 mm.

In other embodiments, the gel assembly 138 is adhered directly to thepatient oriented face 106 in a manner than brings together the opposingedges of each notch caused the gel assembly 138 to cup into a concaveshape. The outer pad layer 142 may be adhered to the gel assembly 138 inan essentially overlapping position and may also be adhered to theenvironmental oriented face 104.

In some embodiments, the cup-like combination of the gel assembly 138,in the inner pad layer 140, and the outer pad layer 142 are positionedbetween the patient oriented face 106 and the environmental orientedface 104, the environmental oriented face 104 comprising the medialenvironmental-face component 108 and the lateral environmental-facecomponents 110 a and 110 b. In this manner, the patient oriented face106 provides a continuous uninterrupted surface, without seams, folds,overlaps, or any other discontinuities, to the subject's head 210 whendeployed thereby minimizing pressure concentrations on the skin of thesubject's head 210.

As can be seen in FIG. 3, the medial edges 111 a and 111 b of the twolateral environmental-face components 110 a and 110 b, respectively, andthe lateral edges 109 a and 109 b of the medial environmental-facecomponent 108 are all preferably curvilinear and convex relative totheir respective component panels 110 a, 110 b and 108 of environmentalsurface 104. Despite such convexly curvilinear nature, duringfabrication of force-distributing cranial support 100, opposite ones ofthese convexly curvilinear edges 109 a-b and 111 a-b are essentiallyopposed to one another such that, if laid flat, they curve in oppositedirections from one another. So positioned and shaped, the medialenvironmental-face component 108 and the lateral environmental-facecomponents 110 a and 110 b are affixed along their facing edges 110 a-band 111 a-b, for instance via sewing, in a manner such that the medialedge of each lateral environmental-face components 110 a and 110 b isaffixed to the lateral edge of the medial environmental-face component108. More specifically, the convexly curvilinear course of medial edge111 a is assembled and joined to align with the oppositely-curvedlateral edge 109 a. Likewise, medial edge 111 b is assembled and joinedto align with the oppositely-curved lateral edge 109 a. As a result, ina seemingly incongruous manner, their respective curvilinear courses areassembled and permanently joined to align with one another despite theiropposite curvature, to unite panels 108, 110 a and 110 b to form aunitary environmental face 104. The result also produces athree-dimensional contour for environmental face 104, which in turncreates a predisposition to flex various other layers offorce-distributing cranial support 100 to thereby form the contour ofoccipital cup 118 in a manner that tends to conform with the occipitalregion 212 of a neonatal subject's head 210. In addition to theincongruous joinder of oppositely curved edges that form internal seamswithin environmental oriented face 104, cephalic edge 114 of forcedistributing cranial support 100 is also formed by the union ofoppositely curved edges 109 c and 107 c. More particularly, the cephalicedge 109 c of the medial environmental panel 108 is concavely curved inthe cephalic direction while the mating cephalic edge 107 c of patientoriented face 106 is convexly curved in the cephalic direction. Again,despite such opposite curvatures, edges 109 c and 107 c are flexed intoalignment and sewn together during fabrication of force-distributingcranial support 100. Such incongruous joinder to form cephalic edge 114further contributes to ensuring the three-dimensional concavity ofoccipital cup 118, as do other incongruous joinders within theconstruction of force-distributing cranial support 100.

The curves of the medial environmental-face component 108 and thelateral environmental-face components 110 a and 110 b are shaped andpositioned in such a manner as to provide a similar amount of concavityas the cup-like combination of the gel assembly 138, the inner pad layer140, and the outer pad layer 142. The piping 130 affixed, for instancevia sewing, around the perimeter of both the environmental oriented face104 and the patient oriented face 106, securing the plurality of layerstherewithin. In other embodiments, the environmental oriented face 104and the patient oriented face 106 are sown around the perimeter of both,effecting the assembly of the force-distributing cranial support 100.

When so placed on an infant, the force distribution apparatus, becauseof its particular features and characteristics, distributes externalforces away from the area of contact between the tissue and an externalsurface as a smaller force over a larger area. Without being limited toany particular theory, this distribution of pressure may reduce skininterface pressures on areas of the soft tissue where compressive forcesare otherwise concentrated and, hence, tend to cause partial or completecapillary collapse. Such capillary collapse may lead to pressure ulcers,pressure sores, skin breakdown, decubitus ulcers, or otherpathophysiologic conditions. The force distribution apparatus may thusbe prophylactically affixed to the human in a manner to reduce pressurein an at-risk area to prevent such pathophysiology.

When affixed to the head of the infant, the force-distributing cranialsupport 100 is configured to reduce compressive forces on soft, flexiblecranial plates that define a cranial cavity. The force-distributingcranial support cradles the head, further promoting the properdevelopment of the infant's head, reducing the incidence, preventing, ortreating the development of plagiocephaly, brachycephaly, anddolichocephaly (referred to collectively as, “positional cranialmolding” or, simply, “cranial molding”). The reduction of thedevelopment of cranial molding may permit the normal growth of braintissue within the cranial cavity, perhaps positively affecting cognitivedevelopmental. In use, the force-distributing cranial support 100 can beapplied to the head of a prematurely born infant, born less than 36weeks gestational age (otherwise known as menstrual age), a full-terminfant, a toddler, or any age in between. The force-distributing cranialsupport 100 can be applied at any time but is especially useful when theinfant is lying in a supine position.

Irrespective of the particular purpose for using the force-distributingcranial support 100, its purpose is achieved by orienting andcircumferentially securing the force-distributing cranial support 100 inplace. To do so, referring again to FIG. 1, the force-distributingcranial support 100 is placed on the subject's head 210, and the firstand second wings 124 a, 124 b are releasably affixed together to closethe head strap portion 120 snugly or securely over the forehead 214 ofthe subject 200. As the first and second wings 124 a, 124 b cometogether, the force-distributing cranial support 100 achieves a deployedshape that is essentially elliptical as viewed from the cephalic—caudalprojection. Surprisingly, the caudal edge arch 134 results in anessentially flat caudal edge 114 and the cephalic edge arch 132 resultsin an essentially flat cephalic edge 112 when so deployed.

In other embodiments, a thermal retention cap is removably attached tothe force-distributing cranial support 100 with a fastening system. Thefastening system may be positioned along the perimeter of the thermalretention cap and proximate the cephalic edge 112 and may comprise ahook and loop apparatus, magnets of opposite polarity, atongue-and-groove mechanism, or any other system capable of removableattachment. A patient-facing surface of the thermal retention cap may becomprised of the textile of the force-distributing cranial support 100and may be constructed of the same plurality of layers as theforce-distributing cranial support 100. In other embodiments, thethermal retention cap may comprise an insulation material configured toretain heat from the subject's head near the subject rather thanescaping to the environment. This may provide a therapeutic benefit tothe subject, especially when the subject is an infant due to the poorinherent thermal regulation abilities of infants. In addition, thethermal retention cap may also be used in conjunction with ahypothermia-inducing fluid-filled headgear system in a manner to preventenvironmental thermal conditions from influencing the cool therapeutictemperature of the headgear system.

Referring to FIG. 4, another preferred embodiment is shown, where theforce-distributing cranial support 100 further comprises a sensor 164and a processing unit (not shown). When the force-distributing cranialsupport 100 is deployed on a subject's head 210, the proximity of theforce-distributing cranial support 100 to the subject's head 210 affordsthe opportunity to sense physical and physiologic variables associatedwith the use of the force-distributing cranial support 100 or thecondition of the subject. The processing unit is in data communicationwith the sensor 164 and may be configured to transform data from thesensor 164 for a display 166 with which it is in data communication, fortransmission to another device or system, or both. The display 166 maybe a flexible liquid crystal display (LCD) affixed to theforce-distributing cranial support 100. The physical and physiologicvariables may be transmitted from the processing unit to the display 166to provide clinical information for the user caring for the subject. Thephysical and physiologic variables may also be transmitted to a remotesystem such as a patient monitoring system, a remote display unit, aclinical network, a patient data management system, or similarinformation management system. The processing unit may also comprise atransmitting unit, configured to enable communication between theprocessing unit and the remote system. The transmitting unit may employany electromagnetic mechanism for data communication. Theseelectromagnetic mechanisms may include but are not limited to physicalconnection of lead wires whether digital or analog in nature, aradio-frequency transmission such as ultrahigh frequency radio waves asspecified in the Bluetooth communication protocol, a radio-frequencyquery system such as radio-frequency identification (RFID) system, or aninfrared transceiver such as specified by the Infrared Data Association(IrDA).

In some embodiments, the sensor 164 is a pressure sensor such as astrain gauge sensor adapted to detect and quantify the pressure betweenthe subject's head and the patient oriented face 106 of theforce-distributing cranial support 100. For minimal interference andreadings that most closely reflect conditions at the head 210, such apressure sensor 164 is preferably mounted within the multiple layers offorce-distributing cranial support 100. For instance, as illustrated inphantom line in FIG. 3, sensor 164 is positioned between the gel layer144 and patient oriented face 106. The processing unit is configured totransform data from the sensor 164 into a numeric value in appropriateunits, for instance millimeters of mercury (mmHg), that are then shownon the display 166. In other embodiments, the processing unit comparesthe pressure detected by the sensor 164 with a threshold value that maybe indicative of a pressure suitable for efficacious use of theforce-distributing cranial support 100. When a pressure sensed exceedsthe threshold value, the display 166 will so indicate. This may providefeedback to the user regarding the proper deployment of theforce-distributing cranial support 100.

In other embodiments, the sensor 164 is a position-detecting sensor suchas an inclinometer, a gyroscope, or an accelerometer. In someembodiments, the sensor 164 is a triple-axis gyroscope device such as anInvenSense ITG-3701 chip. In other embodiments, such a sensor 164 is asix-axis device that combines gyroscope and accelerometer functionalityin the form of laser, fiber optic or solid state devices or the likethat are suitable for being mountable on circuit boards, such as anInvenSense MPU-6500 chip. The sensor 164 detects the orientation of thehead of the subject, for instance whether the subject is in a lyingposition and if so, whether the subject is laying prone, supine, orlateral. Alternately, the sensor 164 detects whether the subject ismoving rapidly as my be the case if the subject is an infant and ismoving in a rapid manner as would be expected during alert play orengagement with the environment. Periodically the processing unitcommunicates with the sensor 164, passing this orientation informationfrom the sensor 164 to the processing unit where it is stored in memorywithin the processing unit. In some embodiments, the orientationinformation is processed within the processing unit, calculatingapproximate times during which the subject was asleep and awake, and foreach of these states, asleep and awake, the fraction of time in asupine, a prone, and a lateral orientation. These data may be shown ondisplay 166, appropriately labeled.

In other embodiments, such data may be communicated by the processingunit to a remote system. When these data are communicated to the remotesystem, the remote system may further process the fractions of time ofsleep and wakefulness, of activity and repose, and of prone, supine andlateral orientation into a clinically engaging report that summarize thesubject's activity and orientation. By way of an illustrative example,when the subject is an infant, the report may indicate that the infantwas placed in a prone position for sleep twenty-eight days of theprevious month. A clinician may consider using this information to guidethe parents or caregiver of the infant to encourage them to place theinfant in a supine position in compliance with the American Academy ofPediatrics (AAP) Safe-To-Sleep guidelines.

In other embodiments, the sensor 164 is an infrared spectroscopeoriented within the force-distributing cranial support 100 to emit lighttowards the subject's head 210. Depending on the amount of light ofvarious wavelengths that is absorbed by the subject's tissue, an amountof light at various wavelengths is reflected back to the infraredspectroscope. Since the absorption is related to the blood within thetissue, the infrared spectroscope provides an indication of local bloodflow and the systemic cardiac cycle. The processing unit obtains thedata from the sensor 164 and may quantify local blood flow in a regionof the subject's head 210, the oxygen saturation of the arterial bloodin the tissue proximate the sensor 164, the heart rate of the subject,the respiration rate of the subject, or an estimate of the fluid statusof the subject, for instance by calculating the pulse pressurevariation. Other calculations based on an infrared spectroscope carealso possible. The aforementioned physiologic variables may becollectively referred to as cardiopulmonary variables. Thecardiopulmonary variables may be transmitted from the processing unit tothe display 166 and may also be transmitted to a patient monitoringsystem, a remote display unit, a clinical network, a patient datamanagement system, or similar information management system.

In still other embodiments, the sensor 164 is an ultrasonic transceiveroriented to insonify the subject's head 210, often through a fontanelwith ultrasound waves and to receive reflected ultrasound wavessubsequently reflected from structures therewithin. The ultrasoundtransceiver is adapted to transmit and received wavelengths betweenabout 20 KHz and about 1 GHz and more preferably between about 1 MHz and20 MHz. The processing unit in data communication with the sensor 164 isconfigured to analyze Doppler shifts in a received signal to assesscranial anatomy, physiology, or pathophysiology. By way of non-limitingexamples, this includes intracranial pressure, cranial cavity volumemeasurements, cerebral blood flow, cerebral blood volume, carotid arteryocclusions, ventricle volume measurements, and parenchymal perfusion.Such measurements and data may be transmitted by the processing unit toa remote display unit, a clinical network, a patient data managementsystem, or similar information management system.

In other embodiments, the sensor 164 is a temperature sensor such as athermocouple or a thermistor. The sensor 164 may be positioned proximatea portion of the subject's head 210 such as by the forehead 214 or atemporal bone. The data from the sensor 164 is processed by theprocessing unit and communicated via a data communication to the display166. Tracking the subject's temperature or changes in the subject'stemperature, especially when the subject is an infant known to have poorintrinsic temperature regulation capabilities, may provide usefulclinical guidance. The clinical guidance may result in a cliniciandeploying the thermal retention cap on the force-distributing cranialsupport 100 or, alternately, detaching the thermal retention cap fromthe force-distributing cranial support 100.

In other embodiments, the sensors 164 include a tympanic temperaturesensor with a sensing element (not shown) connected to a surface of theforce-distributing cranial support 100 at a location over or near one ofthe ear-accommodating arches 126, in an orientation that is directedtoward the adjacent ear 219 of the subject 200. The tympanic temperaturesensor may preferably include a soft memory foam surrounding an infraredtemperature sensor element or other temperature sensor elementincluding, for instance, a thermocouple or thermistor. The infraredtemperature sensor element may be a ZTP-135BS Thermopile IR Sensor (GEMeasurement & Control, Billerica, Mass.). The tympanic temperaturesensor may be held in place in operation with the soft memory foam thatis sized to fit snugly in the ear 219 of the subject, shielding theambient environment from the sensor element in a manner that minimizesthe interference with the measurement of the temperature of the subject.Alternative embodiments and configurations for sensors usable fordetecting the temperature, Sa02 or other health related conditions ofsubject 200 will also be understood by those of skill in the art, whichmay also or alternatively be incorporated in force-distributing cranialsupport 100 as part of sensors 164.

Referring now to FIG. 5, in yet another representative embodiment, anaccessory-ready variation 100′ of the force-distributing cranial support100 further includes an anchor system 168 that allows for connectingand/or supporting accessories to cranial support 100′. But for theunique adaptations described here, the accessory-ready variation 100′ isgenerally identical to the force-distributing cranial support 100 ofFIGS. 1-3. In some embodiments of the accessory-ready variation 100′,the anchor system 168 comprises one or more anchor apparatus 170 (FIG. 5only showing two such apparatus 170, which are particularly designatedas apparatus 170 a and 170 b). Each such anchor apparatus 170 arepreferably securely integrated with the force-distributing cranialsupport 100′ on its environmental surface 104. The principle purpose foranchor apparatus 170 is for connecting and supporting accessories orother objects to the force-distributing 100′. Such anchor apparatus 170are preferably three or more in number, to provide enhanced stabilityfor the support of accessories that may be anchored to anchor apparatus170, particularly for supporting accessories that may contribute to thehealth of the subject, such as for the support of a ventilator tube 300or the like relative to the mouth 218 of the neonatal subject 200. Moreparticularly, anchor apparatus 170 are most preferably four in number,located on environmental surface 104 in two positions on the left sideand two positions on the right side of the subject's head 210—above andbelow each ear 219 when force-distributing cranial support 100 is in anoperative position—as illustrated by the locations of the two anchorapparatus 170 shown in FIG. 5.

Referring to FIG. 6 in conjunction with FIG. 5, each of the anchorapparatus 170 preferably serve their general purpose by providing anchorpositions for securely connecting an accessory securement system 172.Then, once securely connected to the multiple anchor apparatus 170, theaccessory securement system 172 in turn supports an accessory such astube 300 in a suitable position for its intended operation relative tothe mouth 218 of neonatal subject 200.

In some embodiments, each anchor apparatus 170 has a main body 171 thatdefines a primary connection point 174 for connecting objects oraccessories to force-distributing cranial support 100. Each such primaryconnection point 174 is preferably in the form of a female receptacle174 that is sized to receive a corresponding end 188 of the struts 180,182 of accessory securement system 172. The main body 171 of each anchorapparatus 170 may also incorporate a spring-based latch mechanism forreleasably retaining the end 188 of the corresponding strut 180, 182that is inserted into female receptacle 174. The spring-based latchmechanism of each main body 171 is spring-biased to retain thecorresponding end 188 that is fully inserted in the female receptacle174, preferably by spring-biasing a pawl or the like to securely engagea groove 189 or other feature of the strut end 188 when it is fullyinserted in receptacle 174. As is conventional for spring-biased latchmechanisms, the latch mechanism of each main body 171 may be operated toselectively release the strut end 188 by actuating finger release tabs176 on main body 171. Preferably, tabs 176 are embodied as opposingfinger release tabs 176 a and 176 b, which are oriented on oppositesides of each main body 171. The latch mechanisms are configured torelease the strut end 188 by manually squeezing the two opposite fingerrelease tabs 176 a and 176 b toward each other, in a manner such thatthe travel of the finger release tabs 176 is essentially perpendicularto the female receptacle 174. In some preferred embodiments, the anchorapparatus 170 further comprise a cleat 178 located an outer surface ofthe anchor apparatus 170 for enabling a second mode of attaching objectsor accessories relative to force-distributing cranial support 100.

Referring again to FIG. 7, in the illustrated preferred embodiment, fouranchor apparatus 170 include a first pair of the anchor apparatus 170 aand a second pair of anchor apparatus 170 b. Although the view of FIG. 7only shows one anchor apparatus of each such pair (170 a and 170 b,respectively), it should be understood that each such pair includes theone as shown on the right side of the head 210, together with anothersimilar one (not shown) on the opposite, left side of the head 210.

Each anchor apparatus 170 a of the first pair is positioned proximatethe cephalic edge 112 of force-distributing cranial support 100,generally either on the occipital cup portion 118 or on the head strapportion 120. That first pair of anchor apparatus 170 a is referred tocollectively as the cephalic anchor apparatus 170 a. The femalereceptacle 174 of the cephalic apparatus is oriented towards the headstrap portion 120. Similarly, each anchor apparatus 170 b of the secondpair is positioned proximate the caudal tab 122 of the respective leftand right sides of the force-distributing cranial support 100. Thatsecond pair of anchor apparatus 170 b is referred to collectively as thecaudal anchor apparatus. The female receptacles 174 of the caudal anchorapparatus 170 b are oriented essentially parallel to the femalereceptacles 174 of the cephalic anchor apparatus 170 b.

In some embodiments, the accessory securement system 172 comprisescephalic arch member 180, a caudal arch member 182, and a connectingmember 184, the caudal arch member 182 being essentially parallel to thecephalic arch member 180 and the connecting member 184 being affixed tothe cephalic arch member 180 and the caudal arch member 182. Theconnecting member 184 may have the shape of a shaft, an ovoid, atriangle, a plurality of shafts, a stylized heart, a polygon, or othercurvilinear projection. The connecting member 184 may be essentiallycentered relative to the cephalic arch member 180 and the caudal archmember 182. The cephalic arch member 180, caudal arch member 182, andconnecting member 184 may each comprise a material or materials thatprovide a semi-rigid yet resilient structure, somewhat yieldinglyresisting deflection. The cephalic arch member 180, caudal arch member182, and connecting member 184 may each be coated with a soft, wipeablycleanable, hypoallergenic material that facilitates use in a clinicalenvironment and reduces a risk of marring, scratching, injuring, ortraumatizing a subject's head 210 or the skin thereon. The cephalic archmember 180 and the caudal arch member 182 each further comprise twoproximal male ends oriented at the ends opposite of a medial aspect ofthe arch.

A cleat 178 similar to the cleat 178 of the anchor apparatus 170 may beoriented on the cephalic arc member or the caudal arch member 182. Thecephalic arch member 180 and the caudal arch member 182 may also eachfurther comprise a length of elastic material oriented between themedial aspect of the arch and each of the two proximal male ends, theelastic material that resists stretching the medial aspect from the twoproximal male ends. In use, the elastic material may help keep theaccessory securement system 172 proximate the subject's head 210 even asclinically indicated devices are introduced under, in, or on theaccessory securement system 172. In an alternate embodiment, thematerial of the cephalic arch member 180 and the caudal arch member 182comprises an elastic property that resists stretching the medial aspectaway from the two proximal male ends. The two proximal male ends of thecephalic arch member 180 and the caudal arch member 182 are shaped andsized to be insertable into the female receptacle 174 of the anchorapparatus 170. The two proximal male ends of the cephalic arch member180 and the caudal arch member 182 may also be configured to have amating latch mechanism for the anchor apparatus 170. In some preferredembodiments, the cephalic arch member 180 is mateable to the cephalicanchor apparatus and the caudal arch member 182 is mateable to thecaudal anchor apparatus 170.

Referring now to FIG. 7, the connecting member 184 comprises a pluralityof pin receptacles 186 oriented along a face of the connecting member184, the face being oriented distal to the force-distributing cranialsupport 100. The plurality of pin receptacles 186 may be configured asan internal indent.

Referring now to FIG. 8, the accessory securement system 172 furthercomprises an accessory adapter 188. The accessory adapter 188 is adaptedwith a transverse bar 190, which is formed integrally with an accessoryreceiver 192 as well as one or more bar connecting pins 194. The barconnecting pins 194 are located proximate to ends of the bar 190 andoriented perpendicular to a longitudinal axis of the bar 190. In apreferred embodiment, the accessory adapter 188 comprises two barconnecting pins 194 proximate opposite ends of the bar 190 and parallelto one another. The accessory acceptor 190 may be a clasp, port, holder,clamp, or other mechanism suitable to secure a patient care accessoryused in the treatment of the subject. Examples of such patient careaccessories include endotracheal tubes, continuous positive airwaypressure (CPAP) masks, tracheostomy tubes, nasogastric tubes, sensorcables, or any other suitable catheter, cable, wire, mask, eyeshade, orother apparatus. The bar connecting pin 194 provides a secure butreleasable connection to one of the plurality of pin receptacles 186 ofthe connecting member 184. In other embodiments, the connecting member184 is hingedly connected to a covering element having the same shape asthe connecting member 184, the covering element oriented to close downon the face of the connecting member 184 having the plurality of pinreceptacles 186 in a latching manner to secure the bar 190 of theaccessory adapter 188 in place.

Still referring to FIG. 8, the accessory acceptor 190, in an embodiment,comprises an acceptor body and an ovoid shaped aperture defined by theacceptor body, the acceptor body hingedly split in two pieces along alongitudinal axis of the aperture, permitting the acceptor body toaccept one of the patient care accessories. The two pieces of theacceptor body are affixably connected via any acceptable methodincluding latches, magnets, threaded screw and socket, clamps, elasticband, twist connector, or other suitable mechanism. In use, theaccessory adaptor may be positioned on the connecting member 184 in aposition to orient the patient care accessory appropriately for itsintended use. By way of an example, the aperture of the accessoryacceptor 190 may be positioned over a subject's mouth 218 in the eventthat the used patient care accessory is an endotracheal tube, or over asubject's nose 217 in the event that the used patient care accessory isa CPAP mask. In some embodiments, the acceptor body surrounding theaperture is coated in a colored marking material such as an ink thatwill mark the patient care accessory when the body of the accessoryacceptor 190 is secured around the patient care accessory. In use, thismay provide an indication if the patient care accessory position movesor changes relative to the acceptor body. By way of an example, shouldthe endotracheal tube begin to become dislodged, the ink smears on theendotracheal tube now exposed from under the acceptor body, to provide aclearly visible indication to a clinician that the endotracheal tube mayneed to be repositioned in order to avert the risk of an unplannedextubation.

The use of the force-distributing cranial support 100 is now described.The force-distributing cranial support 100 may be deployed by ahealthcare professional or a caregiver onto the subject's head 210. Thedeployment comprises selecting an appropriate size for theforce-distributing cranial support 100 such that the patient orientedface 106 of the occipital cup portion 118 is essentially in contact withthe back 213 of the subject's head 210 and the head strap portion 120 isable to fit around the forehead 214 of the subject's head 210. Thehealthcare professional or a caregiver places the occipital cup portion118 on the back 213 (which encompasses the occipital region 212) of thesubject's head 210 and affixes the first wing 124 a to the second wing124 b.

In use, the head strap portion 120 is moderately tensioned so as toprevent or minimize shifting of the force-distributing cranial support100. The healthcare professional or a caregiver may then rest thesubject onto a surface such as a mattress, in an essentially supineposition. This may be a prophylactic deployment if the healthcareprofessional or a caregiver believes that such a supine position mayresult in an unsuitable pressure concentration on the back 213 of thesubject's head 210, leading perhaps to local ischemia and the subsequentrisk of a pressure ulcer or to a pathophysiologic deformation of thesubject's head 210 and the subsequent risk of plagiocephaly,brachycephaly, and dolichocephaly (referred to collectively as,“positional cranial molding” or, simply, “cranial molding”).

The healthcare professional may periodically remove theforce-distributing cranial support 100 from the subject's head 210 tovisually assess the condition of the skin of the subject's head 210.This visual assessment may include an evaluation of signs of irritation,erythema, papules, edema, vesicular eruption, or diaphoresis. While theforce-distributing cranial support 100 is removed from the subject'shead 210, the healthcare professional may measure the circumference ofthe subject's head 210 to determine if a different sizedforce-distributing cranial support 100 is appropriate. Neonatal patientsin particular and infants in general are likely to have a rapid rate ofgrowth, necessitating the use of progressively larger implements. Theforce-distributing cranial support 100 may be constructed in a varietyof sizes to accommodate subjects of different sizes.

The force-distributing cranial support 100, because of its variouscharacteristics, disperses and distributes the pressure from the area ofcontact between the surface such as the mattress and the subject's head210 to a broader area on the subject's head 210 thus lowering theimparted pressure. In other embodiments, the healthcare professional ora caregiver may interventionally deploy the force-distributing cranialsupport 100 in a similar manner upon observation of an onset of apressure ulcer or other indication of local ischemia on the subject'shead 210. In still other embodiments, the healthcare professional or acaregiver may interventionally deploy the force-distributing cranialsupport 100 in a similar manner upon observation of an onset of cranialmolding.

A subject on whom the force-distributing cranial support 100 is deployedmay be receiving critical medical care simultaneously. This care mayinclude continuous positive airway pressure (CPAP), mechanicalventilation either through a tracheostomy or an orally placedendotracheal tube, enteral feeding, induced hypothermia, extracorporealmembrane oxygenation (ECMO), light therapy for hyperbilirubinemia, orother therapies that may utilize one or more accessories for delivery ofthe medical care. Similarly, these subjects may be instrumented formonitoring of physiologic variables possibly including oxygen saturation(Sp02), cerebral oxygenation, electroencephalography (EEG), skintemperature, tympanic temperature, or other physiologic variables thatmay utilize one or more lead wires or cables. The accessories and leadwires associated with the aforementioned therapies and monitoringmodalities will preferably be secured about the subject's head. By wayof example, in use, in a preferred embodiment, patients treated withmechanical ventilation would be intubated with an endotracheal tube thatwould be secured with the accessory adaptor in a manner restricting themigration of the endotracheal tube either out of the trachea or into theright mainstem bronchus. This may be useful in the case when the subjectis a neonate for whom the endotracheal tube is uncuffed, incontradistinction to endotracheal tubes sized for use on adult subjects.The uncuffed endotracheal tube is more likely to migrate out of thepatient resulting in an unplanned extubation and the subsequentcessation of mechanical ventilation. The semi-rigid yet resilientstructure of the accessory securement system 172 or the elastic materialof the cephalic or caudal arch members 137 allows for sufficientmovement to reduce the risk of blunt trauma to soft tissue of thesubject. For instance, in a neonate, axial movement of a properlysecured endotracheal tube may be limited to +/−15 mm or preferably +/−7mm. By way of another example, the application of a multi-electrode EEGsensor with an associated lead wire set or cable may have its lead wireset or cable secured away from the skin of the subject on the accessorysecurement system 172 or on the cleat 178 of one of the anchor apparatus170. Other monitoring modality lead wires or cables may be similarlysecured. Similarly, tubing or catheters associated with enteral feeding,such as nasogastric tubes, may be secured to the accessory securementsystem 172 or on the cleat 178 of one of the anchor apparatus 170.Securing the aforementioned lead wires, cables, tubing, or cathetersaway from the subject may reduce the risk of pressure ulcers and mayobviate the need for tape or adhesives to be applied to the skin of thesubject.

EXAMPLES

In an unexpected finding, the gel layer 144 dimensioned between about 5mm and about 10 mm in thickness was dramatically effective atdistributing force in a simulated use both by decreasing peak pressureand by increasing the contact area. Indeed, it performs remarkably wellin comparison to toroidal pressure distributing devices that are 50% to400% thicker, dimensioned between about 15 mm and about 20 mm. However,despite being approximately two to three times thicker than the gellayer 144, toroidal pressure distributing devices provide no betterpressure reduction. Moreover, the enveloping of the infant's head thatthe force-distributing cranial support 100 affords provides an inherentstability that may promote a safer or more comfortable environment.

Without being bound to a particular theory, the overall shape and fit ofthe force-distributing cranial support 100 in combination with theparticular aqueous concentration of the gel layer 144 and relativethinness of the gel layer 144 are thought to contribute to theremarkable pressure reducing capabilities of the diminutiveforce-distributing cranial support 100.

The plots shown in FIGS. 9 and 10 further illustrate the remarkablepressure reducing capabilities of force-distributing cranial support100. As reflections of offloading capability on the back 213 of the head210 of a neonatal infant 200, FIGS. 9 and 10 respectively illustratepercentage differences for the peak pressures and contact areasencountered at the points of contact for an infant baby doll (headcircumference 12″ and weight approximately 4 lbs) wearing aforce-distributing cranial support 100 as generally described andillustrated in FIGS. 1-3.

To prepare the plots of FIGS. 9 and 10, pressure and contact area overtime were evaluated using pressure sensors (Tekscan Fscan system) withand without the head 210 of the doll subject being fitted withforce-distributing cranial support 100, and the difference with andwithout is represented in the respective FIGS. 9 and 10. FIG. 9 showsthe percent differences in peak pressure encountered on the occipitalregion 212 of the head 210, when comparing use with and without thepressure-distributing cranial support 100, and FIG. 10 shows thecorresponding percent differences in contact area with and without thepressure-distributing cranial support 100.

For added perspective, four support conditions are shown in each ofFIGS. 9 and 10 (from left to right in each): (1) the left-most bars 401and 501 representing the comparisons when supported on a hard horizontalsurface (designated “Bonn”); (2) the second bars 402 and 502representing the comparisons when supported on a horizontal infantmattress (designated “Bonn Matt”); (3) the third bars 403 and 503representing the comparisons when supported on a hard surface that wastilted from the horizontal (designated “Bonn Tilt”); and (4) the fourth,right-most bars 404 and 504 representing the comparisons when supportedon an infant mattress that was tilted from the horizontal (designated“Bonn Matt Tilt”).

The study results illustrated in FIG. 9 revealed that all of theselected variables indicated significant off-loading of pressure andincreased contact area on the back 213 of the baby doll head 210 for allconditions tested. The force-distributing cranial support 100 offloadedpressures 70% to 86% as illustrated by bars 401 and 402, respectively,in FIG. 9, and all peak pressure conditions were statisticallysignificantly different from each other (see FIG. 9). When an infantmattress was introduced, as represented by both bars 402 and 404, thepressure offloading was further enhanced.

Moreover, despite the thin cross-sectional profile of theforce-distributing cranial support 100, the contact area on the back 213of the head increased between about a low of 220% and to a high of 340%for the conditions tested, as illustrated by bars 503 and 502,respectively, in FIG. 10, and all but one contact area variable wasstatistically significant from each other (see FIG. 10). Whenconsidering just the contact area, the force-distributing cranialsupport 100 on a mattress (bars 502 and 504) was not significantlydifferent than the force-distributing cranial support 100 on a hardsurface (bars 501 and 503, respectively), which may support a view thatuse of an infant mattress does not significantly influence the contactareas achieved through use of the force-distributing cranial support100. While care was taken during data collection to reduce variability,the hard surface condition had higher levels of variability most likelydue to variations on head and neck position of the baby doll. However,even with the variability, statistical significance was found.

A Tekscan pressure sensor was used to collect pressure profiles of theback of the head on an infant baby doll (head circumference 12″ andweight approximately 4 lbs) for the force-distributing cranial support100 on different surfaces (Hard surface, Infant Mattress—1″ hard foamwith vinyl cover) and for different positions (Laying down supine headvertical, Laying down supine head tilted between about 10° to 20°). Thesensor was calibrated by wrapping it around a stainless steel cylinderand an air bladder was used to apply even pressure distribution to thesensor. The calibration was confirmed and adjusted by using a forcetransducer to apply a known force to the sensor.

During data collection, the sensor was taped to lessen sensor creasingprior to application of each condition. Twelve trials for each conditionwere collected for five minutes at one-second intervals. Variables ofinterest are total contact area, peak pressure value, and pressuremapping profile. Averages of the 12 trials for each surface and positionwere calculated.

The results for peak pressure showed a significant pressure reductionfor all of the force-distributing cranial support 100 positions whencompared to a hard surface. There was a significant difference inoffloading peak pressures between the force-distributing cranial support100 and a hard surface (69.8% and 78.7%) for both the vertical head andtilted head conditions. In the test condition with the mattress, theforce-distributing cranial support 100 increases the reductionpercentage to 83.7% for the head-vertical and 83.5% for the head-tiltedcondition relative to the hard surface. Range of peak pressure reductionfor the head positions and surface conditions are from 69.8% to 83.7%reduction. A statistical t-test was used and statistical significancewas found for all pressure variables.

In an unexpected finding, during a simulated infant movement testscenario, it was found that infant movement may dislodge theforce-distributing cranial support 100. In the test scenario, theforce-distributing cranial support 100 was secured to a head of amannequin, shaped and sized similar to that of a neonatal infant, andthis head was mechanically moved in a manner similar to that exhibitedby a neonatal patient. A swaddling was placed in a position relative tobase of the head of the mannequin as would be expected in a clinicalenvironment. This dislodging of the force-distributing cranial support100 occurred even as the force-distributing cranial support 100 wassecured by means of the head strap portion 120 onto the mannequin,occurring either by the caudal edge 114 abutting swaddling typicallyused to wrap an infant during a back-arching movement or by the frictionof the environmental oriented face 104 against bedding material duringshifting of an infant, or both. It was surprisingly found that theseparation of the caudal edge 114 of the force-distributing cranialsupport 100 relative to the proximate edge of the swaddling had a strongimpact on the security and stability of the force-distributing cranialsupport 100. The measure of the caudal to cephalic curve of theoccipital cup portion 118 then is a critical dimension. This criticaldimension needs to extend sufficiently far to cover the occipitalprotuberance but not so far as to abut the expected position ofswaddling. Further, the radius of the concavity of the occipital cupportion 118 is such that the occipital cup portion 118 is essentially incontact with the subject's head 210.

In another unexpected finding during this simulated infant movement testscenario, the low shear material of the patient oriented face 106 mayhave contributed to the force-distributing cranial support 100 becomingdislodged from the head of the mannequin in spite of the snug fitprovided by the concave occipital cup portion 118 and the head strapportion 120. This finding was replicated in healthy human studiesconducted under investigational review board oversight in which it wassurprisingly found that the force-distributing cranial support 100loosened as the infant moved over a sub-one hour period. The addition ofthe grip-providing substance 162 to the patient oriented face 106 in arevised design provided additional stability to the force-distributingcranial support 100 such that it remained secure on the head of theinfant in the healthy human tests. This was a counterintuitive designchange in that the focus had been on minimizing shear stress for theinfant's skin until it was found that the addition of the grip-providingsubstance 162 to the patient oriented face 106 in an appropriate patternresulted in no adverse events relative to skin integrity while providingsufficient stability of the force-distributing cranial support 100.

OTHER VARIATIONS AND COMMENTS

The invention may be embodied in other specific forms without departingfrom the spirit or essential characteristics thereof. As particularexamples, many aspects of the invention will be appreciated through useof alternative embodiments that incorporate particular apparatus andmethods of the prior applications that have been referenced andincorporated herein, or by use of select parts and subassemblies of suchapparatus. The embodiments understood from the foregoing descriptionsare therefore to be considered in all respects illustrative rather thanlimiting on the invention described herein. Indeed, numerous otherfeatures, objects, advantages, alternatives, variations, equivalents,substitutions, combinations, simplifications, elaborations,distributions, enhancements, improvements or eliminations (collectively,“variations”) will be evident from these descriptions to those skilledin the art. Such variations will be especially evident when thesedescriptions are contemplated in light of a more exhaustiveunderstanding of the numerous difficulties and challenges faced by theprior art.

All such variations should be considered within the scope of theinvention, at least to the extent substantially embraced by theinvention as defined in claims that may be associated with thisapplication (including any added claims and any amendments made to thoseclaims in the course of prosecuting this and related applications). Inany case, the scope of the invention is thus indicated by such claimsrather than by the foregoing description, and all changes that comewithin the meaning and range of equivalency of the claims are,therefore, intended to be embraced therein.

All references cited in this specification are hereby incorporated byreference. The discussion of the references herein is intended merely tosummarize the assertions made by the authors and no admission is madethat any reference constitutes prior art. Applicants reserve the rightto challenge the accuracy and pertinence of the cited references.

We claim:
 1. A force-distributing cranial support suitable for a head ofan infant comprising: an occipital cup portion and an operativelyattached head strap portion, said occipital cup portion and said headstrap portion having a caudal edge adapted to be oriented towards a neckof an infant and a cephalic edge adapted to be oriented towards a crownof said head of said infant, wherein said force-distributing cranialsupport has a patient oriented face and an environmental oriented face,said patient oriented face comprising a material having hypoallergenic,biocompatible, non-irritating properties; a gel assembly oriented withinsaid occipital cup portion, said gel assembly comprising a semi-solidmaterial, said semi-solid material adapted to distribute a force of saidhead of said infant applied thereon, said semi-solid materialcontainedly oriented within said gel assembly; and a padded layer, saidgel assembly proximate said padded layer, wherein said padded layer andsaid gel assembly are elements of said occipital cup portion of saidforce-distributing cranial support; wherein said head strap portion isconfigured relative to said occipital cup such that said head strapportion is snugly conformable to a forehead of said infant while saidoccipital cup portion is operatively positioned adjacent to an occipitalregion of said head of said infant, said cephalic edge positioned belowsaid crown of said head, whereby said crown of said head of said infantis uncovered.
 2. The force-distributing cranial support of claim 1,wherein said environmental oriented face further comprises a medialenvironmental-face component, a first lateral environmental-facecomponent, and a second lateral environmental-face component, saidmedial environmental-face component, said first lateralenvironmental-face component, and said second lateral environmental-facecomponent being shaped with convex mutually facing edges such that whensaid mutually facing edges are affixed, said first lateralenvironmental-face component to said medial environmental-face componentand said second environmental-face component also to said medialenvironmental-face component, said combined components of saidenvironmental oriented face adopt a concave three-dimensional shape. 3.The force-distributing cranial support of claim 2, said gel assemblyfurther comprising a medial gel element, a first lateral gel element,and a second lateral gel element, said medial gel element, and saidfirst and second lateral gel elements securely maintained within anenvelope sealed around a perimeter of said envelope, said gel assemblyhaving flexing seams between said medial gel element and said first andsecond lateral gel elements.
 4. The force-distributing cranial supportof claim 3, wherein said envelope comprises a thermoplastic elastomer.5. The force-distributing cranial support of claim 3, wherein said gelassembly is affixed to an inner surface of said environmental orientedface, said flexing seams of said gel assembly aligning with saidmutually facing edges of said medial environmental-face component, saidfirst lateral environmental-face component, and said second lateralenvironmental-face component, whereby said gel assembly assumes saidconcave three-dimensional shape of said environmental oriented face. 6.The force-distributing cranial support of claim 3, wherein said gelassembly further comprises an inferior gel element oriented towards saidcaudal edge and proximate to said medial gel element and said first andsaid second gel element, said inferior gel element maintained withinsaid envelope.
 7. The force-distributing cranial support of claim 1,further comprising a grip-providing substance fixedly applied on aportion of said patient oriented face, said grip-providing substanceoriented to contact said head of said infant and adapted to facilitateand promote the securement of said force-distributing cranial supportduring normal movement of said infant.
 8. The force-distributing cranialsupport of claim 7, wherein said grip-providing substance is a silicone.9. The force-distributing cranial support of claim 7, wherein saidgrip-providing substance is applied to said patient oriented face onsaid occipital cup portion in a pattern around a perimeter of saidoccipital cup portion that leaves a center area of said patient orientedface uncovered by said grip-providing substance, whereby thegrip-providing substance is configured such that when said infant islying in a supine position, the peak pressure exerted on said head ofsaid infant is exerted directly onto said patient oriented face ratherthan directly onto said grip-providing substance, and is furtherconfigured such that said grip-providing substance remains in contactwith said head around said perimeter of said occipital cup portion. 10.The force-distributing cranial support of claim 1, wherein saidoccipital cup portion further comprises: bilateral caudal tabs orientedon either side of said occipital cup portion along said caudal edge; andbilateral ear accommodating arches oriented between said bilateralcaudal tabs and said head strap portion, wherein each of said bilateralear accommodating arches are configured to be positioned proximate to aposterior aspect of an ear of said infant when said occipital cupportion is held adjacent to an occipital region of said head of saidinfant.
 11. The force-distributing cranial support of claim 10, whereinsaid occipital cup portion is dimensioned between said bilateralear-accommodating arches between about seven centimeters and aboutfifteen centimeters.
 12. The force-distributing cranial support of claim1, further comprising a caudal rim member, said caudal rim memberoriented along said patient oriented face proximate said caudal edge ofsaid occipital cup portion whereby said caudal rim member is configuredto lie inferiorly to an occipital protuberance of said head of saidinfant when said occipital cup portion is held proximate said occipitalregion.
 13. The force-distributing cranial support of claim 12, whereina grip-providing substance is oriented on said caudal rim member. 14.The force-distributing cranial support of claim 1, wherein saidsemi-solid material is a hydrogel.
 15. The force-distributing cranialsupport of claim 14, wherein said hydrogel contains a waterconcentration between about thirty-five percent and about fifty percent,whereby said concentration provides a resistance to flow and aresilience to compression from an externally applied force.
 16. Theforce-distributing cranial support of claim 1, wherein said head strapportion further comprises a first wing and a second wing, each of saidfirst and second wings extending from said occipital cup portion andconfigured to releasably attach said first wing to said second wing,across said forehead of said infant.
 17. The force-distributing cranialsupport of claim 16, wherein said first wing further comprises a hookmechanism and said second wing further comprising a loop mechanism, saidhook mechanism and said loop mechanism oriented to cooperatively operatewhereby said first wing is releasably attachable to said second wing.18. The force-distributing cranial support of claim 1, wherein saidpadded layer comprises a polyethylene foam.
 19. The force-distributingcranial support of claim 1, wherein said padded layer further comprisesa medial pad element, a first lateral paid element, and a second lateralpad element, said medial pad element, said first lateral pad element,and said second lateral pad element being shaped with convex mutuallyfacing edges and being affixed to an inner surface of said environmentaloriented face with said medial pad element aligned with said medialenvironmental-side component, said first lateral pad element alignedwith said first lateral environmental-side component, and said secondlateral pad element aligned with said second lateral environmental-sidecomponent.
 20. The force-distributing cranial support of claim 1,wherein said occipital cup portion is dimensioned along an axisdescribed from said cephalic edge to said caudal edge between about sixcentimeters and about nine centimeters.
 21. The force-distributingcranial support of claim 1, further comprising a piping of a flexiblepiping material and a cord around which said flexible piping material islongitudinally wrapped, said flexible piping material stitched into saidcommon perimeter of said patient oriented face and said environmentaloriented face whereby said piping is affixed along at least a portion ofsaid common perimeter.
 22. The force-distributing cranial support ofclaim 1, further comprising an inner padded layer oriented between saidgel assembly and said patient oriented face, said inner padded layerfixedly adhered to said patient oriented face and wherein said paddedlayer is proximate said occipital cup portion.
 23. Theforce-distributing cranial support of claim 1, wherein said occipitalcup portion has a thickness between about 5 millimeters and about 32millimeters.
 24. The force-distributing cranial support of claim 1,wherein said occipital cup portion has a thickness between about 8millimeters and about 16 millimeters.
 25. The force-distributing cranialsupport of claim 1, wherein said head strap portion extends from a sideof said occipital cup portion, configured to wrap around said foreheadof said infant and to releasably affix to a contralateral side of saidoccipital cup whereby said head strap is adapted to maintain saidforce-distributing cranial support in position around said head of saidinfant.
 26. A force-distributing cranial support comprising: a concaveoccipital cup portion and a head strap portion contiguously orientedwith said occipital cup portion, said occipital cup portion and saidhead strap portion further comprising a patient oriented face and anenvironmental oriented face, said head strap portion adapted to fitaround a forehead of an infant whereby said occipital cup is adapted tobe brought into contact with a posterior aspect of a head of saidinfant; a caudal edge oriented towards a neck of said infant and acephalic edge adapted to be oriented towards a crown of said head ofsaid infant; and a gripping material, said gripping material affixed tosaid patient oriented face and adapted to be oriented to contact saidhead of said infant whereby said gripping material promotes resistanceto movement of said head of said infant relative to said patientoriented face and, hence promotes resistance to movement of said head ofsaid infant relative to said cranial deformation preventing device,wherein said gripping material has a thickness of between 50 microns and250 microns; wherein said occipital cup portion further comprises aforce-distributing assembly of one or more force-distributing elements,said force-distributing assembly adapted to distribute a force at acontact point associated with a weight of said head of said infant whensaid head is placed in said occipital cup portion resting on a surface,whereby distributing the force over an area larger than said contactpoint reduces peak pressure; wherein said patient oriented face furthercomprises a material having hypoallergenic, biocompatible,non-irritating properties.
 27. The force-distributing cranial support ofclaim 26, wherein said gripping material covers a portion of saidpatient oriented face.
 28. The force-distributing cranial support ofclaim 26, wherein said environmental-oriented face comprises a flexibletextile.
 29. A force-distributing cranial support suitable for a head ofan infant comprising: a head strap portion; an occipital cup portionoperatively attached to said head strap portion, said occipital cupportion further comprising bilateral caudal tabs and bilateral earaccommodating arches oriented between said bilateral caudal tabs andsaid head strap portion; a caudal edge adapted to be oriented towards aneck of an infant and a cephalic edge adapted to be oriented towards acrown of a head of said infant; a gel assembly formed to have a concaveshape and comprising a gel element of a semi-solid material, saidsemi-solid material adapted to distribute a force of said head of saidinfant applied thereon, said gel element encapsulated within an envelopesealed around a perimeter of said envelope thereby maintaining said gelelements in a fixed orientation and location; a padded layer forciblyadhered to said gel assembly, said padded layer being flexible, wherebysaid padded layer takes on said concave shape of said gel assembly; anda patient oriented face and an environmental oriented face, said patientoriented face comprising a material having hypoallergenic,biocompatible, non-irritating properties, said patient oriented facehaving a grip-providing substance fixedly applied thereon, adapted tocontact said head of said infant, and adapted to facilitate and promotethe securement of the force-distributing cranial support during thenormal movement of said infant, wherein said grip-providing substancehas a thickness between 10 microns and 10 millimeters; wherein saidpadded layer and said adhered gel assembly are elements of saidoccipital cup portion of the force-distributing cranial support; whereinsaid head strap portion is oriented relative to said occipital cupportion such that said head strap portion is adapted to be snuglyconformable to a forehead of said infant while said occipital cupportion is operatively positioned adjacent to an occipital region ofsaid head of said infant, said cephalic edge configured to be positionedbelow said crown of said head, whereby said crown of said head of saidinfant is uncovered and each of said bilateral ear arches are positionedto be proximate a posterior aspect of an ear of said infant.